MAUDE Adverse Event Report: Xenios AG Novalung ultimate kit (US); Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Catalog Number	F32000015
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported an underperforming oxygenator during extracorporeal membrane oxygenation (ecmo) support that required exchange in less than 8 hours, with a second oxygenator having the same reported issue in less than 12 hours.Upon internal review, the user facility stated that 10 of 16 oxygenators required change out in under one week due to failure.Three of these kits have been accounted for, however, this is to capture the remaining 7 kits included in the customer complaint.Data is still being collected from the customer for review.This case reflects an event where a patient on veno-venous ecmo support experienced suboptimal oxygenation with a post-oxygenator arterial oxygen of 118 mmhg on (b)(6) 2026 requiring product exchange.There was no indication of patient serious injury.The complaint sample was not available for product investigation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

• Brand Name: Novalung ultimate kit (US)
• Common Device Name: Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
• Manufacturer (Section D): Xenios AG; director of quality; im zukunftspark 1; heilbronn baden-wurttemberg 74076 ; GM 74076
• Manufacturer (Section G): Xenios AG; director of quality; im zukunftspark 1; heilbronn baden-wurttemberg 74076 ; GM 74076
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; +1(617)417-5172
• MDR Report Key: 50733169
• Report Number: 3012172416-2026-00076
• Device Sequence Number: 10633061
• Product Code: QJZ
• UDI-Device Identifier: 04057224001494
• UDI-Public: 04057224001494
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: F32000015
• Device Lot Number: HSXA1906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Novalung Console (Linux Board).
• Patient Sex: Unknown